Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

Phase 3

Completed

• Conditions: HIV-1 Infections
• Interventions: Drug: darunavir; ritonavir; emtricitabine/tenofovir; Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

• Registration Number: NCT01033760
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

Detailed Description

Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.

After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).

We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.

Study Timeline

• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Study Start: 2010-04
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with acute or primary HIV-1 infection
• Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.
• Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
• Symptomatic Primary infection or CD4 <500/mm3
• written informed consent
• ≥ 18 years old

Exclusion Criteria

• Prior post exposure antiretroviral treatment within six months before enrolment
• Pregnancy or breast-feeding
• HIV-2 infection
• Current malignancy
• Prothrombin time < 50%
• Creatinine clearance < 60 ml/min
• ASAT, ALAT or bilirubin ≥10*N
• Platelets < 25000/mm3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 2	darunavir; ritonavir; emtricitabine/tenofovir	darunavir, ritonavir, emtricitabine/tenofovir
arm 1	raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine	darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

Primary Outcome Measures

Name	Time	Method
To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection	24 months

Secondary Outcome Measures

Name	Time	Method
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24	24 months
Evolution of the CD4 and CD8 between D0 and M24	24 months
Number and type of ARV mutations in virological failures and change in CCR5 tropism	24 Months
Changes in cell-associated HIV-DNA between baseline and M24	24 Months
Tolerability of trial treatments	24 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30	30 months

Trial Locations

Locations (1)

Hôpital Gustave Dron; 🇫🇷 Tourcoing, France